MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CATHERA; CATHETER, CONTINUOUS FLUSH

Model Number	FG15150-0615-1S
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #275636513.Equipment used: vis (m-78210), 203cm ruler (m-83361) document used: dwgsfg15xxx-yyyy-zz rev.F as found condition (condition of returned device): a pipeline flex embolization device and a phenom-27 catheter were returned for analysis within a shipping box; within a sealed plastic biohazard pouch and within a sealed tyvek pouch.Visual inspection/damage location details: the inner diameter (id) of the phenom-27 microcatheter was found to be 0.027¿ per ifu (instructions for use).Per pipeline embolization device instructions for use (ifu): ¿the pipeline embolization device is designed to be delivered through a compatible micro catheter of 0.027¿ inside diameter.¿ therefore, the phenom-27 micro catheter was found to be compatible for use with the pipeline flex embolization device.The pipeline flex was found to have been returned within phenom-27 catheter.The pipeline pushwire was found to be extending ~86.0cm from hub.The pipeline flex was then removed from the phenom catheter through distal tip without issue.(pli-10) the pipeline pushwire was found to be bent at ~33.2cm from proximal end.The hypotube was found to be stretched with ptfe pulled back.The proximal bumper, re-sheathing marker and re-sheathing pad were found to be int act.The dps sleeves were found to be in good condition.No damages were found with the tip coil.The pipeline braid was not returned.No other anomalies were found with the device.(pli-20) no damages were found with the phenom-27 hub.The phenom total length was measured to be ~158.6cm.The useable length was measured to be ~152.0cm.The catheter body was found to be kinked at ~6.6cm and at ~0.3cm from distal tip.The distal tip was found to be punctured.Testing/analysis (including sem reports): the catheter was flushed; water exited the distal tip.The phenom catheter was tested with an in-house 0.026in mandrel.The in-house mandrel was inserted into the phenom hub without issue; however, met resistance at ~0.3cm from distal tip.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿pipeline damaged during delivery/retrieval¿ was confirmed.However, the root cause could not be determined.Possible causes for ¿pipeline damaged during delivery/retrieval¿ include re-sheathing more than 2 times, high force delivery, over-manipulation, delivering/retracting delivery wire against resistance, deploying/re-sheathing braid against resistance and use of incompatible device.Based on the device analysis and reported information, the customer¿s report of ¿resistance/stuck during delivery¿ was confirmed as the pipeline flex returned within the phenom catheter used during the event.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary (see tr-nv12798 - pipeline-catheter interaction and capa (b)(4) based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and tortuous anatomies.In addition, resistance can occur due to patient vessel tortuosity, failure to maintain a continuous flush, or pipeline is pulled back/torqued during delivery.The vessel anatomy was normal in tortuosity.Therefore, the cause could not be determined.Based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ was unable to be confirmed and the root cause could not be determined.In addition, no issue was found during catheter resistance testing with an in-house mandrel.Possible causes for ¿catheter resistance¿ are continuous flush rate too low, catheter or delivery system damage or insufficient delivery system hydration.(reyesr32 2022-04-22) medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the pipeline stent could not be pushed further during the deployment process.When it was withdrawn from the body, it was noticed that the front tip of the stent was accordioned. the device was replaced, and the patient did not experience any injury or complications.Angiographic results post procedure showed slowed down blood flow.The devices were prepared and flushed according to the instructions for use (ifu).The patient was undergoing treatment for an unruptured, amorphous anuerysm located in the left opthalmic artery.The max diameter was 4.1mm, and the neck diameter was 3.7mm.The patient's vessel tortuosity was normal.The landing zone was 2.85mm distal and 3.52mm proximal.The access vessel was the right femoral artery, which was 12.1mm in diameter. dual antiplatelet treatment was administered for the regular treatment course of 7 days.Ancillary devices include a cook 6 sheath, navien 5f guide catheter, synchro 2 guidewire, and phenom 27 microcatheter.Additional information was received indicating the overall resistance was great.There was no damaged observed to the pushwire or catheter.

• Brand Name: CATHERA
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14438007
• Report Number: 2029214-2022-00850
• Device Sequence Number: 5579175
• Product Code: KRA
• UDI-Device Identifier: 00847536041868
• UDI-Public: 00847536041868
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: AU21-029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female